# K962900: Self Retaining Male External Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Sep 16, 1996 after 53 days
- Product code: EXJ (Device, Incontinence, Urosheath Type, Sterile)
- Device class: 1
- Regulation: 21 CFR 876.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940269 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940269: Hollister Non-Rolled Self-Adhesive Urinary External Catheter, Hollister, Inc. (1994) Summary page 1.
- (no number) Mentor Active Cath Self Adhesive Male External Urinary Catheter: named in the summary without a submission number

## Indications for use
The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.

Source page: https://510kreport.com/device/K962900
Methodology: https://510kreport.com/methodology